# K200109: OXY-1 System

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Oct 23, 2020 after 280 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K932252 (1993). 17 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191029: Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac, Medtronic, Inc. (2019) Summary page 4.
- K991864: Rotaflow Centrifugal Pump System, Jostra Medizintechnik AG (2000) Summary page 4.
- K080592: HLM Tubing Set with Bioline Coating, Maquet Cardiopulmonary, AG (2008) Summary page 4.

## Most influential descendants
- K223161: OXY-1 System (2023), 0 descendants of its own
- K222297: CentriMag Pre-connected Pack (2022), 0 descendants of its own

## Recalls of this device
- Dec 14, 2021 · Class I · Z-0550-2022: The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead 

## Indications for use
The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration

Source page: https://510kreport.com/device/K200109
Methodology: https://510kreport.com/methodology